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FDA 510(k)

ALT (ALANINE AMINO-THRANSFERASE)REAGENT

K-Number: K851995 · 1985-05-30

ApplicantAlpkem Corp.
Decision Date1985-05-30
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALT (ALANINE AMINO-THRANSFERASE)REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Alpkem Corp.. It received FDA 510(k) clearance on 1985-05-30 under 510(k) number K851995. The device is classified under product code CKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALT (ALANINE AMINO-THRANSFERASE)REAGENT?

ALT (ALANINE AMINO-THRANSFERASE)REAGENT is a medical device that received FDA 510(k) clearance on 1985-05-30. The listed applicant is Alpkem Corp.. The 510(k) number is K851995.

When did ALT (ALANINE AMINO-THRANSFERASE)REAGENT receive FDA 510(k) clearance?

ALT (ALANINE AMINO-THRANSFERASE)REAGENT received FDA 510(k) clearance on 1985-05-30, under 510(k) number K851995.

Who is the listed applicant for ALT (ALANINE AMINO-THRANSFERASE)REAGENT?

The FDA 510(k) record lists Alpkem Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALT (ALANINE AMINO-THRANSFERASE)REAGENT?

The FDA product code for ALT (ALANINE AMINO-THRANSFERASE)REAGENT is CKA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Alpkem Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K894011TOTAL GALACTOSEK891070PHENYLALANINE (NINHYDRIN REACTION)K890334TOTAL CHOLESTEROL REAGENTK890337TRIGLYCERIDES - GPO REAGENTK890336GLUCOSE (GOD) REAGENTK890332RFA/2 RAPID FLOW ANALYZER W/COMPUTER

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Related Devices (Code: CKA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K120945HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ASTHitachi Chemical Diagnostics, Inc.K113382ACE ALT REAGENTAlfa WassermannK061020DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASEDade Behring, Inc.K020487CARESIDE ALTCareside, Inc.K980028ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)Trace America, Inc.K973869TRACE REAGENT LINE FOR THE COBAS MIRATrace America, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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